5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
FDA 510(k) clearance K093217 · decided 2010-01-21
Clearance details
- K-number
- K093217
- Device name
- 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
- Applicant
- Intuitive Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-10-13
- Decision date
- 2010-01-21
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- NAY
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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| da Vinci SP Surgical System (SP1098) (K251426) | Intuitive Surgical, Inc. | 2025-10-03 |
| da Vinci SP Surgical System (SP1098) (K251817) | Intuitive Surgical, Inc. | 2025-09-10 |
| da Vinci Surgical System (IS5000) (K251227) | Intuitive Surgical, Inc. | 2025-09-08 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci St recall (Z-1117-2015) | Intuitive Surgical, Inc. | 2015-02-13 |
| HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da V recall (Z-1118-2015) | Intuitive Surgical, Inc. | 2015-02-13 |